Effects of Repetitive Transcranial Magnetic Stimulation Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- BNT (Boston Naming Test)
研究概览
简要总结
The aim of this study is to assess the safety and clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia patients.
详细描述
Most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area.
In the present randomized controlled trial, investigators will perform fNIRS prior to rTMS treatment to select the stimulation method. Stimulation site (perilesional or contralesional) and frequency (excitatory high or inhibitory low) will be determined by activation pattern from the fNIRS with language task in individual patients.
The patient who shows a dominant neural activity at perilesional Broca's area on fNIRS scanning will be randomly allocated into two groups: high frequency stimulation group and sham stimulation group. If a patient shows a dominant neural activity at contralesional homologs of Broca's area on fNIRS scanning, the patient will be allocated to a low frequency stimulation group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 yrs old
- •Right-handed
- •Radiologically confirmed left hemisphere stroke within 6 months
- •Fluent in Korean
- •First ever stroke
- •Non-fluent (motor-dominant) aphasia
- •Written informed consent
排除标准
- •Previous medical histories of stroke, cerebral vascular operation,
- •Patients with traumatic brain injury
- •Unable to perform the language task
- •Severe cognitive impairment (MMSE less than 16)
- •Skin lesion in the stimulation site of scalp
- •Metal implants in the body (cardiac pacemaker or aneurysm clip)
- •Pregnancy, breastfeeding
结局指标
主要结局
BNT (Boston Naming Test)
时间窗: up to 2 weeks
speech evaluation tool for measuring the confrontational word retrieval function
次要结局
- LI (Laterality Index; From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemispheric HbO (oxyhemoglobin) or total Hb values, respectively)(up to 6 weeks)
- BNT (Boston Naming Test)(4 weeks)
- WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia)(up to 6 weeks)
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital